MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø6.5X65 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	101-06565
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported post-operative pain and was revised.During revision, the surgeon observed that two denali polyaxial screws were fractured.The devices were explanted and the tips of the screws remain in the patient.This report captures the first of two fractured screws.
Additional Manufacturer Narrative
H3 other text: no product returned.

• Brand Name: POLYAXIAL SCREW; SIZE Ø6.5X65 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18107014
• Report Number: 3004774118-2023-00147
• Device Sequence Number: 12775270
• Product Code: NKB
• UDI-Device Identifier: 10888857002890
• UDI-Public: 10888857002890
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101-06565
• Device Lot Number: ARBV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female